Investigator Complaint Systems

CONMED Corporation • Largo, FL

1d

About The Position

CONMED is a leader in medical technology. We empower healthcare providers worldwide to deliver exceptional outcomes for patients. If you are committed to making a difference and delivering exceptional results, you'll find a group of people here that shares your passion for meaningful work. You'll be supported by a leadership team that promotes engagement through professional development, new challenges and growth opportunities over the course of your career. Come inspire us through your dedication, creativity and exceptional performance - we'll do the same for you! The Complaint Systems Investigator will review, investigate and process domestic and international complaints for Medical Device Reporting (MDR) and International (Vigilance) Device reporting requirements based on FDA Regulations and International [Medical Device Directive (MDD)/Medical Device Regulation (MDR)] Device Reporting requirements.

Requirements

• Associate degree in engineering, chemistry, or other related discipline.
• 2 years of experience in quality or regulatory industry preferred.

Nice To Haves

• Bachelor’s degree in engineering, chemistry, or other related discipline preferred.
• Experience in production, quality or regulatory compliance or equivalent internship(s) preferred.
• Experience in pharmaceutical, medical device, chemical or related industry preferred.
• Working knowledge of QSRs, European Union Directives, ISO 13485 and related International Medical Device regulations preferred.

Responsibilities

• Triage, review and manage the movement of all credit returns/devices related to complaints as needed for further review, analysis and/or root cause investigation.
• Initiate the investigation process by gathering sufficient documentation for risk assessments and investigations.
• Identify and notify appropriate personnel for conducting root cause investigation.
• Assist in determining the need for corrective/preventive actions or other required actions.
• Provide technical support to investigation team and/or product design teams.
• Participate in internal/external audits, corrective/preventive action and product team meetings as required.
• Maintain working knowledge of domestic and international regulations or standards related to Quality System Regulations (QSR), International Standards Organization (ISO), Medical Device Directives (MDD)/Medical Device Regulation (MDR)] and other international country regulations and medical device/adverse event reporting requirements.
• Maintain high level knowledge of products, service/repair processes and manufacturing processes.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees